PainNCT02440880
Dexamethasone With TAP Block Increasing the Duration of the Peripheral Nerve Block in Caesarian Section
A study testing Dexamethasone in addition to TAP block in dose of 4 mg, Dexamethasone in combination with TAP block in dose of 8 mg and Dexamethasone intravenous 4mg+ TAP block in people with Pain, run by Cairo University at 1 site in Egypt.
Trial summary
Nowadays Cesarean sections became the most popular surgery worldwide with the consumption of the hospital resources and the continuous need to decrease the costs, work load and medical stuff engagement. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Dexamethasone in addition to TAP block in dose of 4 mg, Dexamethasone in combination with TAP block in dose of 8 mg and Dexamethasone intravenous 4mg+ TAP block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- May 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Any patient ASA (american society of anesthesia) I or II,
- aged between 18 and 45 scheduled for elective cesarean section.
Who cannot join
- patient refusal,
- age below 18 or above 45 years,
- coagulopathy with INR (international normalized ratio) more than 1.5 or platelets below 100000,
- uncontrolled diabetes, uncontrolled hypertensive, addict patient,
- psychological instability, and
- allergy to the used drugs,
Show all 9Show fewer
- failure of spinal,
- conversion to general of anesthesia,
- failure of application of TAP block.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, Giza Governorate, 1234
HASSAN M ALI, LECTURER, +201001733687, hassan364@hotmail.com
About this study
Nowadays Cesarean sections became the most popular surgery worldwide with the consumption of the hospital resources and the continuous need to decrease the costs, work load and medical stuff engagement. One of the most common problem is the need to control pain post operatively, this issue increase the work load over the pain management team and increase lead to patient in satisfaction.
This study will test the usage of dexamethasone with different doses (4 and 8 mg) either locally or intravenously (I.V.) with the local anesthetics in TAP (transversus abdominis plane) block to prolong the duration of the block and decrease the need of post-operative analgesics.
Read the detailed description
Nowadays Cesarean sections became the most popular surgery worldwide with the consumption of the hospital resources and the continuous need to decrease the costs, work load and medical stuff engagement. One of the most common problem is the need to control pain post operatively, this issue increase the work load over the pain management team and increase lead to patient in satisfaction.(1,2,3) The presence of the adjuvant which can be added to the conventional anesthetic medications can prolong the duration of action and decrease the need for frequent post-operative analgesics.(4,5) The idea of adding a catheter or placing an epidural catheter still have a quite limitation regarding the patients compliance, delayed ambulation and high costs, these limitations redirect the anesthetist again to the use of adjuvant with a single shot block to prolong the duration of it and decrease the need of subsequent analgesics.(6) Dexamethasone proved to be an effective adjuvant in prolongation of the nerve blocks with the question regarding the proper route and dose (7,8,9,10).
This study will test the usage of dexamethasone with different doses (4 and 8 mg) either locally or intravenously (I.V.) with the local anesthetics in TAP (transversus abdominis plane) block to prolong the duration of the block and decrease the need of post-operative analgesics.
- Conditions
- Pain
- Being tested
- Dexamethasone in addition to TAP block in dose of 4 mg, Dexamethasone in combination with TAP block in dose of 8 mg, Dexamethasone intravenous 4mg+ TAP block, Dexamethasone intravenous in addition to TAP block in dose of 8 mg, control
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone in addition to TAP block in dose of 4 mgDrug
Dexamethasone in addition to TAP block in dose of 4 mg
Dexamethasone in combination with TAP block in dose of 8 mgDrug
Dexamethasone in combination with TAP block in dose of 8 mg
Dexamethasone intravenous 4mg+ TAP blockDrug
Also called Dexamethasone intravenous 4mg + TAP block
Dexamethasone intravenous in addition to TAP block in dose of 4 mg
Dexamethasone intravenous in addition to TAP block in dose of 8 mgDrug
Also called Dexamethasone intravenous 8mg+ TAP block
Dexamethasone intravenous + TAP block in dose of 8 mg
controlOther
Also called control group
TAP block without Dexamethasone neither intravenous nor in combination with the block
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | Placebo comparator | TAP block without Dexamethasone neither intravenous nor in combination with the block Receives: Other: control |
| Group 2 (TD8IS) | Experimental | Dexamethasone in combination with TAP block in dose of 8 mg Receives: Drug: Dexamethasone in combination with TAP block in dose of 8 mg |
| Group 3(TD4IS) | Experimental | Dexamethasone in addition to TAP block in dose of 4 mg Receives: Drug: Dexamethasone in addition to TAP block in dose of 4 mg |
| Group 4 (TSID8): | Experimental | Dexamethasone intravenous in addition to TAP block in dose of 8 mg Receives: Drug: Dexamethasone intravenous in addition to TAP block in dose of 8 mg |
| Group5(TSID4) | Experimental | Dexamethasone intravenous 4mg+ TAP block Receives: Drug: Dexamethasone intravenous 4mg+ TAP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of pain according to verbal analogue scale
Measured: THREE DAYS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startMay 2015
- Primary completionNov 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Mohamed Ali, Cairo University
- Investigators
- Hassan Ali, LECTURER, Principal investigator, Anesthesia department, faculty of medicine ,Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440880
- Sponsor's protocol ID
- Qasr Elainy
- Status last verified
- Aug 2016
- First submitted
- 24 Apr 2015
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone With TAP Block Increasing the Duration of the Peripheral Nerve Block in Caesarian Section
- ClinicalTrials.gov ID
- NCT02440880
- Acronym / sponsor ID
- Qasr Elainy
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nowadays Cesarean sections became the most popular surgery worldwide with the consumption of the hospital resources and the continuous need to decrease the costs, work load and medical stuff engagement. One of the most common problem is the need to control pain post operatively, this issue increase the work load over the pain management team and increase lead to patient in satisfaction.
This study will test the usage of dexamethasone with different doses (4 and 8 mg) either locally or intravenously (I.V.) with the local anesthetics in TAP (transversus abdominis plane) block to prolong the duration of the block and decrease the need of post-operative analgesics.
Detailed description
Nowadays Cesarean sections became the most popular surgery worldwide with the consumption of the hospital resources and the continuous need to decrease the costs, work load and medical stuff engagement. One of the most common problem is the need to control pain post operatively, this issue increase the work load over the pain management team and increase lead to patient in satisfaction.(1,2,3) The presence of the adjuvant which can be added to the conventional anesthetic medications can prolong the duration of action and decrease the need for frequent post-operative analgesics.(4,5) The idea of adding a catheter or placing an epidural catheter still have a quite limitation regarding the patients compliance, delayed ambulation and high costs, these limitations redirect the anesthetist again to the use of adjuvant with a single shot block to prolong the duration of it and decrease the need of subsequent analgesics.(6) Dexamethasone proved to be an effective adjuvant in prolongation of the nerve blocks with the question regarding the proper route and dose (7,8,9,10).
This study will test the usage of dexamethasone with different doses (4 and 8 mg) either locally or intravenously (I.V.) with the local anesthetics in TAP (transversus abdominis plane) block to prolong the duration of the block and decrease the need of post-operative analgesics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CONTROL | Placebo comparator | Other: controlTAP block without Dexamethasone neither intravenous nor in combination with the block |
| Group 2 (TD8IS) | Experimental | Drug: Dexamethasone in combination with TAP block in dose of 8 mgDexamethasone in combination with TAP block in dose of 8 mg |
| Group 3(TD4IS) | Experimental | Drug: Dexamethasone in addition to TAP block in dose of 4 mgDexamethasone in addition to TAP block in dose of 4 mg |
| Group 4 (TSID8): | Experimental | Drug: Dexamethasone intravenous in addition to TAP block in dose of 8 mgDexamethasone intravenous in addition to TAP block in dose of 8 mg |
| Group5(TSID4) | Experimental | Drug: Dexamethasone intravenous 4mg+ TAP blockDexamethasone intravenous 4mg+ TAP block |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Any patient ASA (american society of anesthesia) I or II,
- aged between 18 and 45 scheduled for elective cesarean section.
Key exclusion criteria (9 listed)
- patient refusal,
- age below 18 or above 45 years,
- coagulopathy with INR (international normalized ratio) more than 1.5 or platelets below 100000,
- uncontrolled diabetes, uncontrolled hypertensive, addict patient,
- psychological instability, and
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone in addition to TAP block in dose of 4 mgDexamethasone in addition to TAP block in dose of 4 mg | Drug | Group 3(TD4IS) |
| Dexamethasone in combination with TAP block in dose of 8 mgDexamethasone in combination with TAP block in dose of 8 mg | Drug | Group 2 (TD8IS) |
| Dexamethasone intravenous 4mg+ TAP blockAlso: Dexamethasone intravenous 4mg + TAP blockDexamethasone intravenous in addition to TAP block in dose of 4 mg | Drug | Group5(TSID4) |
| Dexamethasone intravenous in addition to TAP block in dose of 8 mgAlso: Dexamethasone intravenous 8mg+ TAP blockDexamethasone intravenous + TAP block in dose of 8 mg | Drug | Group 4 (TSID8): |
| controlAlso: control groupTAP block without Dexamethasone neither intravenous nor in combination with the block | Other | CONTROL |
Primary outcome
level of pain according to verbal analogue scale
Time frame: THREE DAYS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hassan Ali, LECTURER principal investigator
Anesthesia department, faculty of medicine ,Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone in addition to TAP block in dose of 4 mg, Dexamethasone in combination with TAP block in dose of 8 mg and Dexamethasone intravenous 4mg+ TAP block in people with Pain, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hassan Ali (+201001733687, hassan364@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of pain according to verbal analogue scale (time frame: THREE DAYS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2016; AzTrials last refreshed its copy on 6 Nov 2026.